Applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics

The Food and Drug Administration (FDA) is forecasting a funding opportunity titled Applied Regulatory Science Research to Evaluate and Treat Cardiotoxicity of Oncology Therapeutics (FOR-FD-25-015). This program seeks to support research that enhances the detection, monitoring, and treatment of cardiotoxicity associated with oncology therapeutics, with the goal of informing future FDA regulatory decisions. Key areas of interest include standardizing definitions for cardiotoxicity types and grades, developing biomarkers and imaging techniques, creating functional measures for cardiac evaluation, and establishing standardized monitoring plans for clinical trials. Additional priorities involve using risk stratification models to identify high-risk patients, integrating electronic health records for systematic data collection, incorporating patient-reported outcomes related to cardiovascular health, and fostering collaborative networks for data sharing and best practices. Research efforts may also focus on contributing to public databases, innovating treatments for cardiotoxicities, and studying the natural history of these conditions. The FDA anticipates awarding two cooperative agreements, with substantial agency involvement in study design, review of interim deliverables, and ongoing collaboration to ensure alignment with regulatory needs. Eligible applicants include public and private institutions of higher education, nonprofit and for-profit organizations, small businesses, tribal governments and organizations, and various state and local government entities. The application timeline and funding details are forthcoming. For additional information, contact Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610. This opportunity reflects the FDA’s commitment to advancing regulatory science and improving patient outcomes by addressing cardiotoxicity associated with oncology treatments.